NCT04981132

Brief Summary

The study investigates the effects of pain and exercise training via telerehabilitation method on pain, pain beliefs, trunk mobility, functionality, and quality of life in individuals with low back pain caused by facet joint arthrosis. Forty - five individuals are planning to include in the study. Participants will be randomly assigned to one of the three groups: Group 1: Pain education + exercise training group, Group 2: Exercise training group, and Group 3: Control group. The same physiotherapist will make evaluations via an online conference system. Group 1 will have pain neuroscience education and progressive therapeutic exercise training in a session for six weeks, twice a week, and Group 2 will have progressive therapeutic exercise training in a session for six weeks, twice a week, for six weeks, in total twelve sessions. Group 3 participants will be taken to the waiting list. Clinical and demographic data of the 45 participants in the study will be taken pre and post interventions. The primary outcomes are; the Numeric Pain Rating Scale (NPRS) and the Oswestry Disability Index (ODI). Secondary outcomes are the Active Straight Leg Raise Test (A- SLR), The Pain Belief Questionnaire (PBQ), and the Short Form Quality of Life Form (SF-12). Statistical analysis will be run through the SPSS 20.0 package program.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 28, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

October 15, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2022

Completed
Last Updated

August 24, 2023

Status Verified

August 1, 2023

Enrollment Period

7 months

First QC Date

June 21, 2021

Last Update Submit

August 22, 2023

Conditions

Keywords

facet joint arthrosislow back painexerciseeducationtelerehabilitation

Outcome Measures

Primary Outcomes (4)

  • The Numerical Rating Scale

    It is a frequently used scale with proven validity and reliability (Clark 2003, Boonstra 2008), consists of a horizontal line 100 mm long. There are two marks at the beginning and end of the line. The mark at the beginning of the line indicates 0 mm - no pain; the mark at the end of the line - 100 mm - unbearable pain. Subjects will be asked to place a mark on this horizontal line for the maximum pain they feel during rest and activity, and the results will be recorded in cm.

    Pre - intervention

  • The Numerical Rating Scale

    It is a frequently used scale with proven validity and reliability (Clark 2003, Boonstra 2008), consists of a horizontal line 100 mm long. There are two marks at the beginning and end of the line. The mark at the beginning of the line indicates 0 mm - no pain; the mark at the end of the line - 100 mm - unbearable pain. Subjects will be asked to place a mark on this horizontal line for the maximum pain they feel during rest and activity, and the results will be recorded in cm.

    6 weeks later (Post intervention)

  • The Oswestry Disability Index

    The Oswestry Disability Index(ODI) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. Scores between 0-5 are given for each question on the scale consisting of 10 questions. Questions are on travel, social life, sex life, sleeping, standing, sitting, walking, lifting things and personal precautions. Maximum score is 50, minimum score is 0.

    Pre - intervention

  • The Oswestry Disability Index

    The Oswestry Disability Index(ODI) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. Scores between 0-5 are given for each question on the scale consisting of 10 questions. Questions are on travel, social life, sex life, sleeping, standing, sitting, walking, lifting things and personal precautions. Maximum score is 50, minimum score is 0.

    6 weeks later (Post intervention)

Secondary Outcomes (6)

  • Active Straight Leg Raise Test

    Pre - intervention

  • Active Straight Leg Raise Test

    6 weeks later (Post intervention)

  • The Short Form 12

    Pre - intervention

  • The Short Form 12

    6 weeks later (Post intervention)

  • The Pain Beliefs Questionnaire

    Pre - intervention

  • +1 more secondary outcomes

Study Arms (3)

Education+Exercise Group

EXPERIMENTAL

Group 1: Patients will have 15 minutes of pain neuroscience education (PNE) and 30 minutes of progressive therapeutic exercise training (PTE) with the telerehabilitation method.

Behavioral: Pain Neuroscience education + Progressive therapeutic exercise training

Exercise group

EXPERIMENTAL

Group 2: Patients will have 45 minutes of progressive therapeutic exercise training (PTE) with the telerehabilitation method.

Behavioral: Progressive therapeutic exercise training

Control Group

NO INTERVENTION

Group 3: Participants will be taken for the waiting list after evaluation with the telerehabilitation method.

Interventions

The education group will have a comprehensive patient education which includes; description, transmission, representation of pain, central sensitization, neuroplasticity, its relation to body systems, psychosocial and emotional factors affecting pain, pain behavior, and lifestyle changes to cope with pain, etc. Plus, the group will have supervised progressive therapeutic exercises via the telerehabilitation method.

Education+Exercise Group

The exercise group will have supervised progressive therapeutic exercises via the telerehabilitation method.

Exercise group

Eligibility Criteria

Age40 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • volunteering,
  • being the ages of 40 to 64
  • having a diagnosis of Grade 1 or 2 facet joint arthrosis according to Pathria classification
  • having pain for at least 12 weeks, primarily due to facet joint arthrosis
  • having a pain score between 3 and 8 according to the Numerical Pain Scale (NRS)
  • not having received education about pain before,
  • having computer and internet access

You may not qualify if:

  • having a BMI of 30 and above
  • to have had conservative treatment or surgery in the lumbar region in the last 6 months,
  • having severe deformity in the lower extremity
  • having red or orange (pregnancy, disc pathology, infection, fracture, cancer, stenosis, severe osteoporosis, schmorl nodule, cauda equina syndrome, etc.) signs defined for low back pain
  • having a regular exercise habit,
  • having a seronegative rheumatological disease,
  • having general pain syndrome.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University - Cerrahpaşa

Istanbul, Turkey (Türkiye)

Location

Related Publications (13)

  • Clarke CL, Ryan CG, Martin DJ. Pain neurophysiology education for the management of individuals with chronic low back pain: systematic review and meta-analysis. Man Ther. 2011 Dec;16(6):544-9. doi: 10.1016/j.math.2011.05.003. Epub 2011 Jun 25.

    PMID: 21705261BACKGROUND
  • Cottrell MA, Galea OA, O'Leary SP, Hill AJ, Russell TG. Real-time telerehabilitation for the treatment of musculoskeletal conditions is effective and comparable to standard practice: a systematic review and meta-analysis. Clin Rehabil. 2017 May;31(5):625-638. doi: 10.1177/0269215516645148. Epub 2016 May 2.

    PMID: 27141087BACKGROUND
  • Fatoye F, Gebrye T, Fatoye C, Mbada CE, Olaoye MI, Odole AC, Dada O. The Clinical and Cost-Effectiveness of Telerehabilitation for People With Nonspecific Chronic Low Back Pain: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jun 24;8(6):e15375. doi: 10.2196/15375.

    PMID: 32357128BACKGROUND
  • Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.

    PMID: 22133255BACKGROUND
  • Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.

    PMID: 27351541BACKGROUND
  • Moseley L. Combined physiotherapy and education is efficacious for chronic low back pain. Aust J Physiother. 2002;48(4):297-302. doi: 10.1016/s0004-9514(14)60169-0.

    PMID: 12443524BACKGROUND
  • Palacin-Marin F, Esteban-Moreno B, Olea N, Herrera-Viedma E, Arroyo-Morales M. Agreement between telerehabilitation and face-to-face clinical outcome assessments for low back pain in primary care. Spine (Phila Pa 1976). 2013 May 15;38(11):947-52. doi: 10.1097/BRS.0b013e318281a36c.

    PMID: 23238489BACKGROUND
  • Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.

    PMID: 29138049BACKGROUND
  • Saracoglu I, Arik MI, Afsar E, Gokpinar HH. The effectiveness of pain neuroscience education combined with manual therapy and home exercise for chronic low back pain: A single-blind randomized controlled trial. Physiother Theory Pract. 2022 Jul;38(7):868-878. doi: 10.1080/09593985.2020.1809046. Epub 2020 Aug 19.

    PMID: 32812478BACKGROUND
  • Truter P, Russell T, Fary R. The validity of physical therapy assessment of low back pain via telerehabilitation in a clinical setting. Telemed J E Health. 2014 Feb;20(2):161-7. doi: 10.1089/tmj.2013.0088. Epub 2013 Nov 27.

    PMID: 24283249BACKGROUND
  • Turolla A, Rossettini G, Viceconti A, Palese A, Geri T. Musculoskeletal Physical Therapy During the COVID-19 Pandemic: Is Telerehabilitation the Answer? Phys Ther. 2020 Aug 12;100(8):1260-1264. doi: 10.1093/ptj/pzaa093. No abstract available.

    PMID: 32386218BACKGROUND
  • Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.

    PMID: 30178503BACKGROUND
  • Tahran O, Ersoz Huseyinsinoglu B, Yolcu G, Karadag Saygi E, Yeldan I. Comparing face-to-face and internet-based basic body awareness therapy for fibromyalgia: a randomized controlled trial. Disabil Rehabil. 2025 Sep;47(19):4987-4998. doi: 10.1080/09638288.2025.2465597. Epub 2025 Feb 19.

Related Links

MeSH Terms

Conditions

Low Back PainMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc. Pt

Study Record Dates

First Submitted

June 21, 2021

First Posted

July 28, 2021

Study Start

October 15, 2021

Primary Completion

May 15, 2022

Study Completion

May 15, 2022

Last Updated

August 24, 2023

Record last verified: 2023-08

Locations